TherapiePub Date : 2026-05-07DOI: 10.1016/j.therap.2026.04.006
Jennifer Lagoutte-Renosi, Marie-Blanche Valnet Rabier, Simona Berbescu, Fabienne Bozon, Jakub Kowalczyk, Anne-Sophie Brunel, Axel Ursenbach, Pierre Gantner, Quentin Lepiller, Damien Montange, Siamak Davani, Patrice Muret
{"title":"Multiple HIV virological failures related to bictegravir-valproic acid interaction evidenced by therapeutic drug monitoring: A retrospective study.","authors":"Jennifer Lagoutte-Renosi, Marie-Blanche Valnet Rabier, Simona Berbescu, Fabienne Bozon, Jakub Kowalczyk, Anne-Sophie Brunel, Axel Ursenbach, Pierre Gantner, Quentin Lepiller, Damien Montange, Siamak Davani, Patrice Muret","doi":"10.1016/j.therap.2026.04.006","DOIUrl":"https://doi.org/10.1016/j.therap.2026.04.006","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148035062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TherapiePub Date : 2026-05-01Epub Date: 2025-07-03DOI: 10.1016/j.therap.2025.06.006
Myriam Mellou , Bénédicte Lelièvre , Delphine Bourneau-Martin , Christine Le Beller , Véronique Pizzoglio , Gwenaelle Veyrac , Joelle Michot , François Parant , Marie Briet
{"title":"Drug-induced fluorosis: A study based on the national and international pharmacovigilance databases","authors":"Myriam Mellou , Bénédicte Lelièvre , Delphine Bourneau-Martin , Christine Le Beller , Véronique Pizzoglio , Gwenaelle Veyrac , Joelle Michot , François Parant , Marie Briet","doi":"10.1016/j.therap.2025.06.006","DOIUrl":"10.1016/j.therap.2025.06.006","url":null,"abstract":"<div><h3>Objectives</h3><div>Despite the widespread use of fluorinated medicines – with approximately 20% of the drugs marketed in 2020 containing fluoride compounds – the association between these medications and fluorosis remains under-recognized. This study aimed to identify medications most likely to induce fluorosis in real-world clinical settings using pharmacovigilance databases.</div></div><div>Despite the widespread use of fluorinated medicines – with approximately 20% of the drugs marketed in 2020 containing fluoride compounds – the association between these medications and fluorosis remains under-recognized. This study aimed to identify medications most likely to induce fluorosis in real-world clinical settings using pharmacovigilance databases.</div><div><h3>Methods</h3><div>A descriptive and disproportionality study was conducted using French national (FPVB) and international pharmacovigilance databases (VigiBase®). Cases of fluorosis were extracted from Vigibase® up to July 8, 2024, using the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms “fluorosis”, “fluoride increased” and “fluorosis dental”. French cases were subsequently extracted from the FPVB. Disproportionality signals were evaluated by calculating the reporting odds ratio (ROR) and corresponding 95% confidence interval (CI).</div></div><div>A descriptive and disproportionality study was conducted using French national (FPVB) and international pharmacovigilance databases (VigiBase®). Cases of fluorosis were extracted from Vigibase® up to July 8, 2024, using the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms “fluorosis”, “fluoride increased” and “fluorosis dental”. French cases were subsequently extracted from the FPVB. Disproportionality signals were evaluated by calculating the reporting odds ratio (ROR) and corresponding 95% confidence interval (CI).</div><div><h3>Results</h3><div>A total of 72 cases of suspected drug-induced fluorosis were identified in VigiBase®. The most frequently reported adverse effects were musculoskeletal disorders (<em>n</em> <!-->=<!--> <!-->39, 54.2%), dental disorders (<em>n</em> <!-->=<!--> <!-->11, 15.3%), and eyes and visual disorders (<em>n</em> <!-->=<!--> <!-->8, 11.1%). Two-third of the cases (<em>n</em> <!-->=<!--> <!-->52) were classified as serious. In 40% of cases (<em>n</em> <!-->=<!--> <!-->29), the outcome was favorable. Voriconazole, sodium fluoride, fluconazole and ciprofloxacin were identified as single suspects. Disproportionality signals were detected for sodium fluoride (ROR<!--> <!-->=<!--> <!-->2305.7; 95% CI [1143.9; 4647.3]), voriconazole (ROR<!--> <!-->=<!--> <!-->1415.4; 95% CI [891.5; 2247.3]), fluconazole (ROR<!--> <!-->=<!--> <!-->110.4; 95% CI [52.9; 230.3]), fludarabine (ROR<!--> <!-->=<!--> <!-->87.3; 95% CI [31.8; 239.3]) and ciprofloxacin (ROR<!--> <!-->=<!--> <!-->7.1; 95% CI [2.2; 22.4]). The 16 cases from the FPVB provided more detailed information, including the","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"81 3","pages":"Pages 224-233"},"PeriodicalIF":1.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144675648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TherapiePub Date : 2026-05-01Epub Date: 2025-06-25DOI: 10.1016/j.therap.2025.06.005
Romain Batton , Fabien Lamoureux , Marion Beuzelin , Jean-Philippe Rigaud , Antoine Marchalot
{"title":"Case report d’une intoxication volontaire mortelle avec de la mirtazapine et de la venlafaxine compliquée d’un pharmacobézoar massif","authors":"Romain Batton , Fabien Lamoureux , Marion Beuzelin , Jean-Philippe Rigaud , Antoine Marchalot","doi":"10.1016/j.therap.2025.06.005","DOIUrl":"10.1016/j.therap.2025.06.005","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"81 3","pages":"Pages 273-276"},"PeriodicalIF":1.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144650623","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TherapiePub Date : 2026-05-01Epub Date: 2025-07-30DOI: 10.1016/j.therap.2025.07.001
Victoria Ugolini , Nadine Petitpain , Didier Menzies , Dominique Swiegot , Audrey Fresse , Isabel De La Fuente Garcia , Anne-Cécile Vuillemin
{"title":"Safety of SARS-CoV-2 vaccination of pregnant women: Luxembourg's cohort study and literature review","authors":"Victoria Ugolini , Nadine Petitpain , Didier Menzies , Dominique Swiegot , Audrey Fresse , Isabel De La Fuente Garcia , Anne-Cécile Vuillemin","doi":"10.1016/j.therap.2025.07.001","DOIUrl":"10.1016/j.therap.2025.07.001","url":null,"abstract":"<div><h3>Aims of the study</h3><div>European countries rapidly advised coronavirus disease 2019 (COVID-19) vaccination during pregnancy based on the evidence of first and reassuring data, especially with mRNA vaccines. Besides the close European pharmacovigilance monitoring, Luxembourg set up a prospective study cohort of women vaccinated during pregnancy to collect maternal and embryofetal outcomes.</div></div><div>European countries rapidly advised coronavirus disease 2019 (COVID-19) vaccination during pregnancy based on the evidence of first and reassuring data, especially with mRNA vaccines. Besides the close European pharmacovigilance monitoring, Luxembourg set up a prospective study cohort of women vaccinated during pregnancy to collect maternal and embryofetal outcomes.</div><div><h3>Methods</h3><div>The study was conducted between June 2021 and October 2023, based on the national vaccination registry. Women were contacted by email and all reported events were retrospectively reviewed by an expert group.</div></div><div>The study was conducted between June 2021 and October 2023, based on the national vaccination registry. Women were contacted by email and all reported events were retrospectively reviewed by an expert group.</div><div><h3>Results</h3><div>The cohort involved 2335 vaccinated pregnant women of which 476 (20.4%) provided an answer, with 383 (80.5%) reporting no adverse events, 88 (18.5%) reporting a total of 90 adverse events (five reports not assessable). Vaccines were almost exclusively messenger RNA (mRNA) vaccines. Between the women who reported an adverse event and those who did not, no significant difference was identified for vaccine rank and pregnancy trimester. Among the 90 reported events, 73 (81,9%) were considered as without link with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccination. Among the 17 adverse events having a non-excluded link with the vaccine, 16 (94%) had a favorable outcome and/or no pathophysiological explanation in regard to the vaccine. Rates of congenital anomalies and miscarriages were reassuringly lower than in the general population.</div></div><div>The cohort involved 2335 vaccinated pregnant women of which 476 (20.4%) provided an answer, with 383 (80.5%) reporting no adverse events, 88 (18.5%) reporting a total of 90 adverse events (five reports not assessable). Vaccines were almost exclusively messenger RNA (mRNA) vaccines. Between the women who reported an adverse event and those who did not, no significant difference was identified for vaccine rank and pregnancy trimester. Among the 90 reported events, 73 (81,9%) were considered as without link with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccination. Among the 17 adverse events having a non-excluded link with the vaccine, 16 (94%) had a favorable outcome and/or no pathophysiological explanation in regard to the vaccine. Rates of congenital anomalies and miscarriages were reassuringly lower than","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"81 3","pages":"Pages 244-255"},"PeriodicalIF":1.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970182","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Impact of urine drug screening on opioid agonist treatment maintenance with buprenorphine in primary care in France: A cluster-randomized trial","authors":"Julie Dupouy , Vanessa Rousseau , Nicolas Authier , Paolo Di Patrizio , Gaetan Gentile , Valérie Gibaja , Catherine Laporte , Laurent Letrilliart , Christine Maynié , Joëlle Micallef , Michel Mallaret , Stéphane Oustric , Emilie Bérard , Maryse Lapeyre-Mestre","doi":"10.1016/j.therap.2025.07.003","DOIUrl":"10.1016/j.therap.2025.07.003","url":null,"abstract":"<div><h3>Introduction</h3><div>To assess the impact of onsite urine drug screening tests (OS-UDTs) in general practice compared with that of routine medical care on opioid agonist treatment (OAT) retention at six months in opioid-dependent patients initiating buprenorphine.</div></div><div>To assess the impact of onsite urine drug screening tests (OS-UDTs) in general practice compared with that of routine medical care on opioid agonist treatment (OAT) retention at six months in opioid-dependent patients initiating buprenorphine.</div><div><h3>Methods</h3><div>In this cluster-randomized controlled trial, general practitioners (GPs) working in primary care and regularly managing patients treated with buprenorphine were invited to participate and were randomly assigned to the intervention or routine care group. GPs (cluster level) were asked to include 1–10 patients starting buprenorphine (individual level). The intervention included: (1) a training session on OS-UDTs; (2) the supply of OS-UDTs at GPs’ offices; and (3) performing an OS-UDT before the first prescription of buprenorphine. The primary outcome was OAT retention at 6 months.</div></div><div>In this cluster-randomized controlled trial, general practitioners (GPs) working in primary care and regularly managing patients treated with buprenorphine were invited to participate and were randomly assigned to the intervention or routine care group. GPs (cluster level) were asked to include 1–10 patients starting buprenorphine (individual level). The intervention included: (1) a training session on OS-UDTs; (2) the supply of OS-UDTs at GPs’ offices; and (3) performing an OS-UDT before the first prescription of buprenorphine. The primary outcome was OAT retention at 6 months.</div><div><h3>Results</h3><div>Among the 97 GPs included (intervention group: 49; control group: 48), 17 GPs included at least one patient, totaling 39 patients: 23 in the intervention group and 16 in the control group. Retention at 6 months was similar: 8 patients (34.7%) in the intervention group and 7 (43.8%) in the control group (OR<!--> <!-->=<!--> <!-->0.69 [95% CI: 0.18–2.56], <em>P</em> value<!--> <!-->=<!--> <!-->0.57). The patients were mainly men (69.2%), aged 39.3<!--> <!-->±<!--> <!-->11.6 years. All 13 patients in the intervention group who returned the acceptability questionnaire rated as “normal medical practice” the GP asking for OS-UDT for the management of OAT.</div></div><div>Among the 97 GPs included (intervention group: 49; control group: 48), 17 GPs included at least one patient, totaling 39 patients: 23 in the intervention group and 16 in the control group. Retention at 6 months was similar: 8 patients (34.7%) in the intervention group and 7 (43.8%) in the control group (OR<!--> <!-->=<!--> <!-->0.69 [95% CI: 0.18–2.56], <em>P</em> value<!--> <!-->=<!--> <!-->0.57). The patients were mainly men (69.2%), aged 39.3<!--> <!-->±<!--> <!-->11.6 years. All 13 patients in the intervention group who returned th","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"81 3","pages":"Pages 212-223"},"PeriodicalIF":1.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970245","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}